Life Sciences

Structured Authoring & Content Management for Life Sciences

With so much information to manage, organizations in highly regulated industries such as life sciences have a distinct need for comprehensive content management solutions that help them author documents more quickly and more efficiently.

Traditional CMS solutions, while effective for handling complete manuscripts of information, are too rigid to truly manage the information that life sciences organizations generate. Locked inside of documents, the information may be discoverable, but it cannot be re-used efficiently without copying and pasting which is error-prone and essentially untraceable. Further, changes made to one area of a document will not flow through to other materials that utilize the same information leading to inconsistencies and regulatory risks.

Dx4 from DitaExchange is a structured content authoring and management solution that enables organizations to create information in components or “topics” that can be authored, reviewed and approved individually, then organized using document “maps” to form complete documents such as study protocols, SOPs, medical information, labeling and more. By creating information in this manner, topics are written and approved only once, able to be re-used many times, and automatically updated everywhere and every time a new document is published. Common uses for life sciences organization are:

  • Study Documents: Consistent reuse of content across studies addressing synopsis documents, protocols, study reports, etc.
  • Global Labeling: Consistent reuse of content across Company Core Datasheet (CCDS), Company Core Safety Information (CCSI), Summary of Product Characteristics (SmPC) and United States Prescribing Information (USPI).
  • Pharmacovigilance System Master File (PSMF): Providing a solution for complying with EU regulations and specifically addressing the EMA requirement of responding within seven (7) days of notification.
  • SOP management: Consistent reuse of standard content (e.g. Tasks, etc.) that are common between documents.
  • Chemistry, Manufacturing and Controls (CMC) document solution: Quality and consistency achieved through intelligent content reuse between documents such as Risk Management Plans (RMP), Periodic Safety Update Reports (PSUR), etc.

Dx4 runs on the Microsoft SharePoint platform with Microsoft Word as the user interface – saving money by utilizing solutions that organizations already know – and use.